Events

Rappel de NOVALIS TX LINEAR ACCELERATOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par VARIAN MEDICAL SYSTEMS INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    90596
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-10-28
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Rapid arc and vvmat treatment may deliver as dynamic arc on incorrectly configured system. under these circumstances dynamic dose rate and gantry speed features as well as avoidance sectors (range of gantry rotation where no dose should be delivered) that may be part of a vmat plan are not recognized and dose delivered does not match the treatment plan.

Device

NOVALIS TX LINEAR ACCELERATOR
  • Modèle / numéro de série
    Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: H272309); Model Catalog: 21EX (Lot serial: H272216); Model Catalog: 21EX (Lot serial: H272158); Model Catalog: 21EX (Lot serial: H272157); Model Catalog: 21EX (Lot serial: H272910); Model Catalog: 21EX (Lot serial: H271926); Model Catalog: 21EX (Lot serial: H271663); Model Catalog: 21EX (Lot serial: H271662); Model Catalog: 21EX (Lot serial: H272310); Model Catalog: 21EX (Lot serial: H271941)
  • Description du dispositif
    Novalis TX Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.